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In a strongly-worded opinion column for The Indian Express on the Ranbaxy fraud published last week, Amir Attaran of the University of Ottawa rightly calls on the Indian government to do more to ensure that drugs produced in India are safe and effective.

But Attaran is wrong is when he uses references to the fraud and to India’s shortcomings in drug safety improvement as a rhetorical device to delegitimize arguments that the Indian government has advanced to oppose global anti-counterfeit initiatives.

Rather than addressing these arguments, Attaran slams the Indian government’s position as “foiling global efforts to improve medicine quality,” and accuses it of “cynical diplomacy” meant to “shelter India’s pharmaceutical industry from outside scrutiny.” Continue reading →

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The EU’s industry commissioner says trade in counterfeit medicines in the Union has exceeded its worst fears, according to German daily Die Welt. “The number of counterfeit medicines arriving in Europe … is constantly growing. The European Commission is extremely worried,” the commissioner, Gunter Verheugen, said yesterday. 34 million tablets have been seized in 2 months from various custom points, he said.

Verheugen did not name names. But an AFP report based on Verheugen’s interview to the German daily pointed out that a July EU report had identified India as a large source of many of the fake pharmaceuticals seized in 2008.

That is embarassing, even shocking. If it is true.

But the EU’s definition of counterfeit is elastic. It stretches to include generics of products currently under patent protection in the EU – even if they are in transit to other countries. It is this expansive definition that has led to seizures of Indian drug shipments at EU custom points, and the tarring of India a as a significant source of counterfeits, says D G Shah, secretary-general of the Indian Pharmaceutical Alliance. In recent months, tens of drug shipments from well-known Indian companies such as Dr Reddy’s, Macleods, and Cipla that were merely passing through EU ports on their way to countries in Latin America have been seized, in response to complaints from patent-holding companies such as Sanofi-Aventis, and Novartis. These drugs were however not under patent in the buyer countries.

Given that India is a huge exporter of generic drugs to those countries, and that transit via Europe is a preferred route, then is it any surprise that India is such a large source of ‘counterfeits’?

New Delhi has so far been ineffective in preventing these seizures. It has belatedly reacted by taking the EU to dispute settlement in the WTO. But that’s clearly the beginning rather than the end of the issue as Verheugen’s latest interview – probably intended to keep the issue alive – indicates.